DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group III (claims 31-36) in the reply filed on 08/11/2025 is acknowledged. However, because Applicant has amended the claim set to so that all claims are now method claims, the Examiner has decided to withdraw the initial restriction requirement, and allow for examination of claims 1, 3-6, 22-26, 31-36, and 38-40.
Applicant elects the species midodrine salt, which is stated to read on all claims except for claim 34. The species election is maintained for examination.
Thus, the claims examined in this action are: 1, 3-6, 22-26, 31-33, 35-36, and 38-40.
Priority
The present application is a National Stage entry of International application PCT/IB2021/055750 filed 06/28/2021, which claims the benefit of Foreign application PT116531 filed 06/26/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 12/22/2022, in the matter of Application N° 18/003,129. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1, 3-6, 22-26, 31-36, and 38-40 are pending.
Claims 34 is withdrawn from consideration as directed to non-elected species.
Claims 1, 3-6, 22-26, 31-33, 35-36, and 38-40 are presented for examination and rejected as set forth below.
Claim Objections
Claim 1 is in improper form and must be objected to. 37 CFR § 1.75: One or more claims may be presented in dependent form, referring back to and further limiting another claim or claims in the same application. Claim 1 refers to claim 31. That is not referring back. See also MPEP 608.01(m).
Claim 31 recites “wherein paroxetine, and/or paroxetine salt are not use as hair volume modulator” is a misspelling of “used”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites “natural polymers derivative” which is indefinite because it is unclear how far one can deviate from the listed parent compounds and yet still remain within the metes and bounds of the invention claimed. The Examiner suggests removing the term or replacing it with the specific species in mind.
Claim 31 recites “the hair modulator” for which there is no antecedent basis, which is indefinite. The examiner suggests that “the bioactive agent” may have been intended instead of “the hair modulator.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 33 is not further limiting of claim 31. It recites the same limitation already in claim 31. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5, 22-25, 31-33, 35-36, and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Goren (WO2020023084A1; published 1/30/2020, compared to the priority date of 06/26/2020).
Applicant’s claims (focused on mainly independent claim 31 (see also similar independent claim 32)) are directed to a method of hair modulation comprising topically administering a bioactive agent to skin of a mammal, wherein the bioactive agent is selected from a group consisting of: dipyridamole, dipyridamole salt, rivastigmine, rivastigmine salt, paroxetine, paroxetine salt, ethacrynic acid, ethacrynic salt, midodrine, midodrine salt, topiramate, topiramate salt, entacapone, entacapone salt, or mixtures thereof, wherein the hair modulator is a hair color modulator and/or a hair volume modulator; wherein paroxetine, and/or paroxetine salt are not use as hair volume modulator. Claims depending from claim 31 (see also claim 32) further limit the topical formulation and method of use.
For method outcomes of the claim set, note that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). However, weight could be given to a method outcome in the event of unexpected results. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In addition, an unexpected method outcome intended to break the obviousness of a rejection must be commensurate in scope with the claims (e.g., if only a single species demonstrates a single unexpected method outcome, the written claim should reflect that and not incorporate other species/outcomes that are not supported by the unexpected results, which would otherwise lead to a maintaining of the obviousness rejection).
Furthermore, the Examiner accepts “prevention” of defective production of melanin (instant claim 25), as enabled, as melanin defects can be caused by UV light, and there are pathways to support the outcome of preventing it. However, Applicant’s results should be commensurate with the outcome, and the burden is on the Applicant to explain the results (as it’s not clear where there is support for midodrine’s effects on melanin – see Table 2 of Applicant’s Specification).
Applicant has elected midodrine salt, as the elected species, for which the rejection will be focused on. The Examiner recognizes midodrine to be involved in hair modulation such as straightening in Table 2 (pg 31) of the Specification.
Goren teaches bioactive agents for hair loss (abstract) by contracting the arrector pili muscle to prevent hair plucking under stress [0013]. Goren teaches formulations in the form of styling products [0046] and a method of applying (Goren – claim 8).
Regarding claim 31-32 and 39-40: Goren teaches a method of applying midodrine compositions (Goren – claims 8 and 14, [0056]) (where salts of other active agents are demonstrated as suitable for topical application and effect, and thus, salts are taught as obvious variations of free based active agents, see [0057, 0058]) which is topically applied (Goren – claim 1) in formulations for the skin [0036, 0039, 0046] to prevent hair loss (reads on hair modulation) (abstract) with direction toward human scalp and hair [0033, 00129-00130], Goren – claims 67-69). Note also that midodrine can be used in combination with ethacrynic acid, dipyridamole, rivastigmine, paroxetine, etc. in the disclosure [0049]; thus, the method of topical application of these agents to human scalp and hair is obvious.
Regarding claims 1, 3, 5 and 23-24: Goren teaches the bioactive agent in 0.1-35 wt% [0051] (thus, within the claimed range and encompassing the amount demonstrated in the Specification of Table 2 on pg 31), thickeners [0053], preservatives such as EDTA or sodium metabisulfite (in 0.1-0.5 wt%) [0053], alcohols/glycols [0053], fatty acids [0053], and excipients [0053].
Regarding claim 22: Goren teaches many formulations such as creams, gels, foams, conditioners, etc. [0046].
Regarding claims 25, 33, and 35: The language, regarding defective melanin, color modulation, and volume modulation in hair, is for intended uses, and is not given weight unless supported by unexpected results that supports the claim limitation scope of the method, ingredients, and method outcome. Such that, specific active ingredients should be tied to specific unexpected method outcomes that are supported by the data, so that the scope is commensurate with the unexpected outcomes.
Regarding claims 36 and 38: Goren teaches prolonged release systems by encapsulation[0045], and makes mention of liposomes [0070].
Thus, the instant method claimed appears to be little more than the selection of art-known elements according to their known utility within a single prior art reference, teaching the desirability of selecting such components, and obvious thereby, that the composition of the instant invention is obvious. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.).
Further note that because Goren teaches the midodrine and the claimed amount applied to the scalp, the discovery of a method to apply topical midodrine to style hair is merely the discovery of an unappreciated property of the prior art method: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). To sum up, since an ingredient and its properties are inseparable, midodrine is inherently a hair shape-modifying compound, and subjects that use Goren’s method with Goren’s amount of midodrine would find favorable hair styling properties, as a result of the method of midodrine application, as taught by Goren. Thus, application of midodrine is expected to allow for hair shaping, as in the method disclosure of Goren. To distinguish Goren from the instant method, Applicant may attempt to specify a patient population or condition for treatment or other limitations (i.e., amounts, etc.) that is supported by unexpected results.
Claims 1, 3-6, 22-26, 31-33, 35-36, and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Goren (WO2020023084A1; published 1/30/2020), as applied to claims 1, 3, 5, 22-25, 31-33, 35-36, and 38-40, and in further view of Hermann (US20100080761A1).
In summary, Goren teaches the elements of the instant method for topical application of a midodrine salt composition to the scalp/hair, except for specific thickeners such as xanthan gum (instant claim 4), specific alcohols such as glycerin (instant claim 6), and self-tanning (instant claim 26).
Hermann teaches a composition and method of modifying human hair growth and skin/hair pigmentation (abstract), where formulations can also be in the shape of styling products (Hermann – claim 20).
Herman teaches thickeners [0082] such as xanthan gum [0273], alcohols such as glycerol (also called glycerin) [0197-0198], tanning agents [0080-0081] for self-tanning (Hermann – claim 19) in a topical formulation for hair (abstract, Hermann – claims 11-12)).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of applying a topical midodrine formulation of Goren by adding the thickeners, alcohols, and tanning agents of Hermann to the formulation because tanning is desirable in the field of cosmetics [0004] and thickeners/alcohols are ingredients typical of topical cosmetic formulations (where Goren teaches carriers for the formulation [0070] and thickeners [0053]). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Because Goren and Hermann are both directed to preventing hair loss and in the form of styling products, it would be obvious to incorporate the specific ingredients taught by Hermann into Goren’s formulations.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 10/16/2025
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614